OSL · Control, Fecal Occult Blood
Hematology · 21 CFR 864.6550 · Class 2
Overview
| Product Code | OSL |
|---|---|
| Device Name | Control, Fecal Occult Blood |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Classification Rationale
Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | Bionostics, Inc. | Oct 1, 2010 | SESE |
Top Applicants
- Bionostics, Inc. — 1 clearance
